EMA Releases June 2025 PRAC Safety Updates for EU-Autho…
The European Medicines Agency (EMA) has released updated safety signal recommendations from its PRAC committee on June 2, 2025.This update r…
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CDE (China) Publishes Guideline for Biologics Registrat…
On February 9, 2025, the Center for Drug Evaluation (CDE) announced the release of the “Guideline for Acceptance Review of Biological …
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US FDA Announces Draft Guidance on AI Use in Regulatory…
On January 6, 2025, the U.S. Food and Drug Administration (FDA) announced the release of a draft guidance titled “Considerations for the U…
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DINAVISA (Paraguay) Approves New Guideline for Good Eva…
On December 2, 2024, the National Directorate of Sanitary Surveillance (DINAVISA) introduced the “Guide to Good Evaluation Practices f…
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MHLW (Japan) Encourages Use of Real-World Data (RWD) fo…
On October 7, 2024, Japan’s Ministry of Health, Labor, and Welfare (MHLW) issued a significant notification encouraging the use of Real-Wo…
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China Approves Carbon Ion Therapy, Marking Cancer Treat…
On September 29, 2024, the National Medical Products Administration (NMPA) approved the registration of the Carbon Ion Therapy System. This …
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